Penile pump with side release mechanism

ABSTRACT

A pump and valve assembly for an implantable prosthesis is provided with an internal actuating bar positioned such that when any portion of the housing is compressed, the check valves within are opened allowing for deflation of the cylinders. The pump and valve assembly also includes a textured surface over a portion of the housing to allow for quick identification of the component, as well as to make it easier for the patient to grasp it. The valve assembly further comprising an actuating bar which has ribs to enhance the spring force applied to a flow valve, a support structure to support and appropriately position the actuating bar, and a check valve made of metal with a segment covered with a plastic material.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of related patentapplication Ser. No. 09/749,075 entitled “PENILE PUMP WITH SIDE RELEASEMECHANISM” which was filed on Dec. 27, 2000, and claims the priority ofprovisional application Serial No. 60/295,326 entitled “PENILE PUMPIMPROVEMENTS” which was filed Jun. 1, 2001 (the entire contents of eachof which are herein incorporated by reference).

BACKGROUND

[0002] This invention generally relates to a pump and valve assembly forinflating a prosthesis. More particularly, the invention relates topressure-based mechanisms that inhibit spontaneous inflation of theprosthesis, including stiffening and support mechanisms that alsoimprove the function of the valve.

[0003] One common treatment for male erectile dysfunction is theimplantation of a penile prosthesis. Such a prosthesis typicallyincludes a pair of inflatable cylinders, which are fluidly connected toa reservoir (typically liquid filled) via a pump and valve assembly. Thetwo cylinders are normally implanted into the corpus cavernosae of thepatient and the reservoir is typically implanted into the patient'sabdomen. The pump assembly is implanted in the scrotum.

[0004] During use, the patient actuates the pump and fluid istransferred from the reservoir through the pump and into the cylinders.This results in the inflation of the cylinders and thereby produces thedesired penis rigidity for a normal erection. Then, when the patientdesires to deflate the cylinders, a valve assembly within the pump isactuated in a manner such that the fluid in the cylinders is releasedback into the reservoir. This deflation then returns the penis to aflaccid state.

[0005] Presently, the pump and valve assembly used in such implantableprostheses share certain similar characteristics. For example, theyinclude fluid pathways allowing the flow of fluid to and from thereservoir, as well as to and from the cylinders. This fluid flow iscontrolled by one or more check valves positioned in the fluid pathwayswithin the housing of the assembly.

[0006] A compressible pump bulb is also attached to the housing and isin fluid communication with the various fluid pathways therethrough. Inorder to inflate the cylinders, the compressible pump bulb is actuatedby the patient, thereby urging fluid past the check valves into thecylinders. In order to deflate the cylinders, the valve housing isgrasped and squeezed (through the patient's tissue), causing the variouscheck valves to unseat and allow fluid to flow back to the reservoir.

[0007] Since the pump and valve assembly is positioned within thepatient's scrotum, the various components of the assembly must be small.As a result, manipulation of the pump and valve assembly is sometimesdifficult. For example, patients requiring the use of penile prosthesisdiscussed herein are oftentimes elderly and have a reduced dexterity asa result of aging. Thus, in some instances, even locating the devicewithin the tissue can be a challenge, let alone identifying the correctportion of the assembly to actuate. More specifically, with somepatients, it may be difficult to determine whether the housing portionof the assembly that leads to release or deflation of the cylinders isbeing grasped or whether the bulb portion which would be used to inflatethe cylinders is being grasped.

[0008] Notably, the length of the valve assembly is determined (at leastin one direction) by the size of the various check valves and thedistance such valves must move in order to open and close the variousfluid passageways. As a result, such a pump and valve assembly typicallyis longer in a direction parallel with the check valves. Moreover, inorder to release the check valves in an assembly configured in thismanner, the patient must grasp the narrower, shorter side walls of theassembly and compress them together. Since such a configuration canpresent challenges insofar as the spring tension of the check valves atthe time of desired deflation is typically at a maximum while thesurface area of the assembly which must be compressed in order to causesuch deflation is at a minimum. This condition can lead to a situationwhere the patient has difficulty actually compressing the assembly, orin extreme circumstances, actually loses grip of the assembly duringsuch attempts at deflation.

[0009] Although the existing devices function with extreme efficiencyand reliability, for some patients it appears there is a desire for apump and valve assembly in an implantable prosthesis that improvesoperative manipulation of the assembly. One such prosthesis pump isdisclosed in co-pending U.S. patent application Ser. No. 09/749,075,entitled “Penile Pump With Side Release Mechanism,” which is assigned tothe Assignee of the present invention and is incorporated herein byreference. However, the operational efficiency of the prosthesis pumpcould be further improved by optimizing the function of the checkvalves.

[0010] Metal on metal contact can cause undesired wear of componentsover time. This can affect the performance of any product. In the pumpand valve assembly, the check valve and spring engage one another at anend of the check valve to inhibit movement. Typically, at least aportion of the check valve and spring are made of a metal material suchas stainless steel. The repeated application of a spring force by thespring onto the end of the check valve tends to wear or degrade thecontact portions of the check valve and spring. This metal on metalcontact over time negatively impacts the performance of the valveassembly.

[0011] The orientation of the pump and valve assembly creates acondition where the spring applies a force in both the axial andsideways directions onto the check valve, during actuation of theprosthesis pump. The axial force acts to move the check valve poppetinto the valve assembly, while the side force has the unintendedconsequence of pushing the check valve sideways causing the valve to tipsideways. When the check valve is pushed sideways into the valvehousing, the valve housing deforms which causes the check valve to bemisaligned. This results in the check valve being restrained from movingaxially into the valve housing to reach its open position.

[0012] Finally, the repeated exertion of axial and side forces of thespring on the end of the check valve tends to cause a reduction in thestiffness of the of the spring. Specifically, the spring is a thinelongate member having a bent portion. As a patient grasps the narrower,shorter side walls of the assembly and compresses them together, thespring flexes inwardly to force, via axial and side forces, the checkvalve to move to an open position. When the patient releases the sidewalls of the assembly the spring returns to its original position,permitting the check valve to return to a closed position. The repeatedflexing of the spring may cause a reduction in stiffness of the spring,particularly at the bend. This reduction in stiffness may lead to thespring deflecting during actuation in an unintended manner, which canpermanently deform the spring. Permanent deformation of the spring hasthe undesired effect of inhibiting the full axial travel of the checkvalve between the open and closed positions.

[0013] There exists a need to provide a prosthetic penile implant thatreduces the wear of the contact point of the check valve and the spring.There is a desire to improve the function of the valve assembly byprevention of deformation of the valve housing and misalignment of thecheck valve. There is a need to provide a barrier to sideways movementof the check valve when moving between the open and closed positions.Additionally, there is a desire to increase the strength and stiffnessof the spring to prevent the spring from deflecting during actuation andprevent permanent deformation of the spring.

BRIEF SUMMARY OF THE INVENTION

[0014] The present invention provides various features which taken aloneor in combination with one another provide for an improved pump andvalve assembly for an implantable prosthesis. The present pump and valveassembly includes a pump bulb that must be differentiated from the valvehousing when inflation of the cylinders is desired. The pump bulb itselfhas dimensions that are somewhat different than the remainder of thehousing. However, to supplement differentiation between the bulb and thevalve housing, the valve housing is provided with a textured surface sothat even through tissue the patient is able to readily discern whicharea comprises the pump bulb and which area comprises the valve housing.This is important in that the pump bulb is compressed for inflationwhile the valve housing is compressed for deflation.

[0015] The pump assembly of the present invention is also configuredsuch that it has a length longer than its width, with its internal checkvalves running parallel with the length. To release fluid from theinflated cylinders, the internal check valves are actuated so that theymove in a direction parallel to the length, until they open. To achievethis action directly, the opposing sides of the width of the valvehousing are compressed. This compression causes actuation of theinternal check valves.

[0016] In addition, an actuating bar is positioned within the valvehousing parallel with and extending along at least one of the sides ofthe length. An arm attached to the actuating bar extends along a portionof one of the sides of the width in close proximity to the tip of one ofthe check valves. Thus, the configuration of the actuating bar causes itto engage and open the check valve allowing fluid to flow from thecylinder to the reservoir. Furthermore, the patient can grasp the valvehousing in virtually any orientation and when pressure is applied, theactuating bar will act either directly or indirectly to open theappropriate check valves. Thus, so long as the patient grasps anyportion of the pump and valve assembly other than the pump bulb,compression will result in the desired opening of the check valves whichwill allow the cylinders to deflate.

[0017] Furthermore, since the patient can grasp the valve housing alongthe sides of the length, i.e., surfaces with larger surface area, lesspressure need be applied to achieve the successful opening of the checkvalves. In other words, by increasing the surface area that is engagedby the patient's fingers and appropriately positioning the actuatingbar, less force need be exerted by the patient to achieve the desiredresult.

[0018] The textured surface of the valve housing not only helps thepatient identify the correct portion of the pump and valve assembly toactuate, it also serves to prevent slippage once the patient begins tocompress the housing. Thus, what is achieved is an efficient andergonomic pump and valve assembly for an implantable prosthesis. Thepump and valve assembly can advantageously be formed from a minimalnumber of components. That is, all that need be molded are a valve blockand a corresponding pump bulb which surrounds the valve block. Thevarious check valves can be inserted into the valve block and thenplaced within the interior of the pump bulb, thus forming a completedassembly. This results in certain manufacturing efficiencies, thusreducing both cost and time of production.

[0019] To further improve the operational efficiency of the pump andvalve assembly, the check valve is made of a metal material with aplastic member disposed over a segment of the metal material. Theplastic segment of the check valve prevents undesired frictional metalon metal contact with the actuating bar, and prevents premature wearingof the contact point of the two components.

[0020] To further improve the life of the valve assembly, ribs, thatextend across a bend, are added to the actuating bar. This modificationincreases the strength and stiffness of the spring and prevents theactuating arm from deflecting during actuation. In turn, full axialtravel of the check valve is ensured. Increasing the strength of thebend also prevents permanent deformation of the spring when normaldeflection occurs during actuation of the valve assembly. Another rib isdisposed along the actuation face of the actuating bar to limitdeformation of the actuation face during actuation of the valveassembly.

[0021] To improve the ease of deflation, a stiff poppet support wrapsaround the valve body and rests against a portion of the check valve.The poppet support has a shelf that provides smooth surface for aportion of the check valve to slide along. The poppet support contactsthe check valve and prevents undesirable sideways movement of the checkvalve against the valve body. The positioning and configuration of thepoppet support thus allows the check valve to easily move axially intothe valve body to an open position. This results in improved operationalefficiency of the check valve and an extended operating life.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022]FIG. 1 is a perspective view of a pump and valve assemblyaccording to the present invention.

[0023]FIG. 2 is a front sectional view of the pump and valve assemblyillustrated in FIG. 1.

[0024]FIG. 3 is a top sectional view of the pump and valve assemblyillustrated in FIG. 1, shown in a state where the cylinders are beingdeflated.

[0025]FIG. 4 is a top sectional view of the pump and valve assemblyillustrated in FIG. 1, shown in a state where the check valves are in adeactivated position.

[0026]FIG. 5 is a top sectional view of the pump and valve assemblyillustrated in FIG. 1, shown in a state where the check valves are in apumping position.

[0027]FIG. 6 is a side sectional view of the pump and valve assemblyillustrated in FIG. 1.

[0028]FIG. 7 is an exploded perspective view of an alternativeembodiment of the present invention.

[0029]FIG. 8A is a side view of the reservoir poppet with a plasticportion of the embodiment of FIG. 7.

[0030]FIGS. 8B and 8C are more detailed illustrations of portions of thereservoir poppet, with FIG. 8B showing a poppet taper and FIG. 8Cshowing a previous design.

[0031]FIG. 9 is perspective view of the actuating bar of the embodimentof FIG. 7.

[0032]FIG. 10A is a top sectional view of the embodiment of FIG. 7.

[0033]FIG. 10B is a sectional view of the embodiment of FIG. 7 showingthe elements when the cylinders are inflated.

[0034]FIG. 10C is a sectional view of the embodiment of FIG. 7 showingthe elements actuated to afford flow of fluid from the cylinders to thereservoir.

[0035]FIG. 11 is a perspective view of the poppet support of theembodiment of FIG. 7.

[0036]FIG. 12 is a sectional view of the embodiment of FIG. 7.

DETAILED DESCRIPTION OF THE INVENTION

[0037] Referring to FIG. 1, a pump and valve assembly is illustrated andgenerally referred to as 10. Pump and valve assembly 10 includes twodifferent sections: valve housing 12 and pump bulb 15. Pump bulb 15 is acompressible member, defining a chamber more clearly shown in FIG. 2.Valve housing 12 is fluidly coupled to pump bulb 15 and contains thevarious other working components of pump and valve assembly 10. Pump andvalve assembly 10 will be fluidly coupled to a reservoir and a pair ofcylinders (not shown). This is accomplished through tubing connected toreservoir coupling 25 and cylinder couplings 30, which are integral withvalve housing 12. Pump and valve assembly 10 is configured such thatpump bulb 15 extends from one end of valve housing 12, while reservoircoupling 25 and cylinder couplings 30 extend from the other. Thus, whenimplanted in the patient, reservoir coupling 25 and cylinder couplings30, and the fluid tubing they are coupled to, are oriented toward thepatient's abdomen, while the pump bulb 15 is disposed in the oppositedirection. Therefore, when pump bulb 15 is grasped by a patient, thereis no interference from or contact with the tubing coupled to reservoircoupling 25 and cylinder couplings 30.

[0038] Valve housing 12 is illustrated as being generally rectangular,having a first major panel 35 that is longer than first minor panel 45.The length of first major panel 35 is determined by the distancerequired to incorporate the various check valves described below andallow their proper functioning. Likewise, first minor panel 45 need onlybe long enough to incorporate the width of these check valves and onceagain allow their proper functioning. Of course, some consideration canbe given to the optimal diameter of the fluid tubing and couplingsconnecting pump and valve assembly 10 to the reservoir and cylinders.Though shown as being generally rectangular, valve housing 12 can takeon any configuration (and dimension) so long as the check valvescontained therein operate correctly. The illustrated configurationgenerally minimizes the volume required for valve housing 12 to operateeffectively. Thus, the net result is that first major panel 35 isgenerally longer than first minor panel 45.

[0039] Referring to FIGS. 1 and 2, the internal configuration of pumpand valve assembly 10 will be described. Two separate molded componentsare utilized to form pump and valve assembly 10. That is, valve block 20is combined with shell 17 to form the completed unit. Pump bulb 15 andvalve housing 12 are a single, integral unit referred to as shell 17that substantially surrounds valve block 20. As illustrated, shell 17includes valve housing 12 which surrounds valve block 20. Alternatively,shell 17 could be a smaller component that does not surround valve block20, but is simply coupled to it. In either case, only two moldedcomponents need be provided to complete the device. These components canbe formed from silicone or any other appropriate material.

[0040] The use of only two molded components to form pump and valveassembly 10 is advantageous. Previous devices generally have four ormore molded components which must be individually put together. Only twocomponents can be bonded in a single step. Bonding includes heating,using adhesive, or various other joining techniques. The two bondedcomponents then take time to set up before the next component can beadded. Thus, a four component device results in a fairly longmanufacturing process having increased costs associated therewith.

[0041] With the present device, valve block 20 is molded and the variousvalve components are inserted into place. Shell 17 is then attached andbonded. Thus, only a single bonding or adhering step is required tocomplete the product. This greatly increases throughput, decreasescosts, and decreases manufacturing time without sacrificing quality ordurability.

[0042] Located within valve block 20 are a plurality of fluidpassageways coupling reservoir coupling 25 and cylinder couplings 30 topump bulb 15 through bulb passageway 95 via medial passageway 60.Disposed within medial passageway 60 are two spring-actuated poppets: areservoir poppet 65 and a cylinder poppet 75, which respectively andselectively abut reservoir poppet valve seat 85 and cylinder poppetvalve seat 90. Cylinder poppet 75 is an uncomplicated, ball-shaped orconical-shaped check valve. Reservoir poppet 65 is an elongated memberhaving a somewhat more complicated shape. The configuration of reservoirpoppet 65, along with the configuration of valve block 20 along medialpassageway 60 is designed to allow the proper operation of the poppetswhile also preventing spontaneous inflation. The functionality andoperability of this arrangement is discussed in co-pending applicationsSer. No. 09/749,292, filed on Dec. 27, 2000, and entitled “PressureBased Spontaneous Inflation Inhibitor,” and Ser. No.______,(Attorney-Docket No. AMS-039) filed concurrently herewith, and entitled“Pressure Based Spontaneous Inflation Inhibitor With Penile PumpImprovements,” the entire disclosures of which are herein incorporatedby reference.

[0043] During a compression of pump bulb 15, fluid is forced from theinternal chamber of pump bulb 15 through bulb passageway 95, causingcylinder poppet 75 to open and allow fluid to flow through cylindercouplings 30 into the respective cylinders. When pump bulb 15 isreleased, cylinder poppet 75 closes under spring pressure. The vacuumgenerated by pump bulb 15 causes reservoir poppet 65 to unseat itselfand allow fluid to flow from the reservoir through reservoir coupling 25so that fluid once again fills pump bulb 15. Repeated compressions areperformed to entirely inflate the cylinders to the patient'ssatisfaction.

[0044] When it is desired to deflate the cylinders, the patientcompresses valve housing 12 by squeezing first minor panel 45 towardssecond minor panel 50. As this occurs, the outer wall of valve housing12 engages actuating bar arm 130 which engages reservoir poppet tip 70,causing reservoir poppet 65 to unseat itself as well as unseatingcylinder poppet 75. Fluid is then able to flow from the cylinders to thereservoir through medial passageway 60. When satisfactorily deflated,the patient releases valve housing 12, allowing reservoir poppet 65 andcylinder poppet 75 to reseat themselves and prevent fluid flow.

[0045] To perform the above described deflation process, the patient maycompress first minor panel 45 and second minor panel 50. In somepatients, however, it may be difficult to achieve this compressionbecause of the relatively small size of first and second minor panels 45and 50. Likewise, it may be difficult for certain patients to graspvalve housing 12 in this manner since valve housing 12 may slip out ofposition between the patient's fingers. Thus, the present pump and valveassembly 10 provides an actuating bar 100 that allows the patient tograsp the first major panel 35 and second major panel 120 (asillustrated in FIGS. 3-5).

[0046] Referring to FIG. 3, the operation of actuating bar 100 isillustrated. Actuating bar 100 is disposed within valve block 20 byfrictionally securing one end of actuating bar 100 into valve blockinterface 125 which securely holds it in place. Actuating bar 100extends substantially along the length of major panel 120. Actuating bararm 130 is integrally coupled with actuating bar 100 and generallyextends substantially along the length of first minor panel 45.Actuating bar 100 is comprised of a suitable material, such as stainlesssteel or plastic. FIG. 3 illustrates a configuration of actuating bar100 when a patient is compressing valve housing 12. The configurationillustrated in FIG. 4 is that of a deactivated state. In this state, thepatient does not intend to inflate (nor deflate) the cylinders. Therelationship between reservoir poppet 65 and valve block 20 in the areaof medial passageway 60 is such that spontaneous inflation is prevented.FIG. 5 illustrates a pumping state. Reservoir poppet 65 is moved to theright (as illustrated) and tip 70 abuts arm 130. When pump bulb pressureis sufficient, cylinder poppet 75 will be unseated. FIG. 4 illustratesthe position of actuating bar 100 in a deactivated state, that is, whenthe patient is not compressing valve housing 12.

[0047] Returning to FIG. 1, major panels 35 and 120 contain a texturedsurface 40, containing a plurality of raised sections. These raisedsections make it easy for the patient to identify and distinguish valvehousing 12 from pump bulb 15 and also allow the patient to grasp itbetter. Furthermore, because major panels 35 and 120 are relativelylarge in comparison to minor panels 45 and 50, it is easier for thepatient to grasp and compress these major panels 35 and 120.

[0048] Referring once again to FIG. 3, when major panels 35 and 120 arecompressed towards one another, actuating bar 100 is deflected from theposition illustrated in FIG. 4 to the position illustrated in FIG. 3.Thus, by engaging reservoir poppet tip 70, actuating bar arm 130 forcesreservoir poppet 65 to move towards and open cylinder poppet 75. Morespecifically, actuating bar 100 is generally parallel with second majorpanel 120 in the deactivated stage. When engaged, actuating bar 100 isdeflected towards first major panel 35. Because of the angle betweenactuating bar 100 and actuating bar arm 130, actuating bar arm 130 iscaused to move towards reservoir poppet tip 70, as well as first majorpanel 35. Insofar as this movement is defined by the internal wall ofvalve housing 12, actuating bar arm 130 moves to the positionillustrated in FIG. 3, engaging and opening reservoir poppet 65. Ofcourse, this does not preclude the patient from grasping first minorpanel 45 and second minor panel 50 and compressing them towards oneanother. If this is done, reservoir poppet 65 will likewise beeffectively unseated. As such, it should be noted that the patient cangrasp valve housing 12 in numerous orientations and a compression willeffectively either directly engage reservoir poppet 65 or causeactuating bar 100, and more particularly actuating bar arm 130 to engageand open reservoir poppet 65. Thus, the patient need not maintain anyparticular orientation of valve housing 12 while deflating thecylinders. That is, any grip achieved on the valve housing 12 can beutilized to effectively open the poppets.

[0049] The configuration of major panels 35 and 120, including texturedsurface 40, will allow patients to easily identify the portion of valvehousing 12 having a larger surface area and to grip it more effectively.When doing so, it may seem to the patient that less force need beapplied in order to unseat reservoir poppet 65. That is, the springtensions involved are constant for cylinder poppet 75 and reservoirpoppet 65. However, because of the larger surface area of major panels35 and 120, as compared to minor panels 45 and 50, the patient needapply less force in order to successfully actuate the device.

[0050] The configurations illustrated in FIGS. 4 and 5 differ only inthat reservoir poppet 65 is in different positions with respect to valveblock 20, depending upon whether the device is in a deactivated state asin FIG. 4 or in a pumping state as in FIG. 5. This is more acharacteristic of the spontaneous inflation preventing mechanism asmentioned above, rather than being directly related to the operation ofactuating bar 100. Of note, actuating bar arm 130 is configured toreceive reservoir poppet tip 70 during the pumping stage as illustratedin FIG. 5. That is, during the compression of pump bulb 15 fluidpressure will force reservoir poppet 65 to its right most position asillustrated in FIG. 5. Because of the configuration of actuating bar arm130 in its unbiased position, it will not interfere with this operation.

[0051]FIG. 6 illustrates a side sectional view of pump and valveassembly 10. Actuating bar 100 only extends along a portion of valveblock 20. When a patient engages first major panel 120, actuating bar100 will be relatively small in comparison to the surface area definedby the patient's finger. To further facilitate the ease with which thepatient can compress actuating bar 100 and effectively unseat reservoirpoppet 65, valve block 20 is enhanced by valve block tabs 115, whichhelp define valve block recess 110 within which actuating bar 100 isseated. Thus, when the patient engages first major panel 35, moving ittowards second major panel 120, this movement is enhanced by theflexibility of valve block tabs 115 allowing a larger portion of firstmajor panel 35 to deflect into valve block recess 110.

[0052] The ease with which the patient can identify, grasp and compressthe relevant portion of pump and valve assembly 10, may ultimatelydetermine the patient's overall satisfaction with the device. FIG. 6illustrates yet another factor which serves to facilitate this. Thewidth of pump bulb 15 is defined as A, while the width of valve housing12 is defined as B. Notably, the width A of valve housing 12 is smallerthan the width A of pump bulb 15. The relevant factor is that pump bulb15 is sized differently than valve housing 12. It does not matter whichcomponent is larger or smaller.

[0053] Thus, when the patient grasps pump and valve assembly 10, thereare several factors that can be utilized to determine which portion thepatient is grasping. First, the orientation of pump bulb 15 towards thebottom is an initial indicator. The textured surface 40 of the majorpanels 35 and 120 is a secondary indicator and the relative sizedifference between pump bulb 15 and valve housing 12 is a tertiaryindicator. These components also work together along with actuating bar100 to make it easier for the patient to compress valve housing 12 andopen the internal poppets, allowing the cylinders to be deflated. Thisis accomplished because major panels 35 and 120 are larger and easier tograsp and their compression towards one another actuates actuating bar100 which in turn actuates and opens reservoir poppet 65. The texturedsurface 40 makes it easier for the patient to grip valve housing 12during this process. Finally, the configuration of actuating bar 100 canbe configured to provide positive feedback to the patient that they aresuccessfully opening the valves to allow for deflation. That is,actuating bar 100 can be provided with a bent area configured such thatwhen actuating bar 100 is actuated, it will cause a clicking sensationthat is audibly or physically sensed by the patient to let them knowthat they have sufficiently compressed valve housing 12. Otheridentifying devices or configurations could be used as well.

[0054]FIGS. 7-12 illustrate an alternative embodiment of pump and valveassembly 300 in which certain modifications have been made to furtherimprove performance. FIG. 7 shows an exploded view of the alternativepump and valve assembly 300 with an improved actuating bar 310, a pumpbulb 316, an improved check valve 318, and a poppet support 320.Assembly 300 comprises a valve block 317 for housing fluid passagewaysthat inter-connect inflatable cylinders and a reservoir (not shown), asdiscussed in the embodiments above. Actuating bar 310, having aplurality of ribs 328 and 330, attaches to a side of valve block 317 andis positioned to engage an end of a reservoir poppet 318. Reservoirpoppet 318 is a check valve that operates to control fluid flow into andout of the reservoir, and is to be positioned within the passageway ofvalve block 317. Poppet support 320 is to be disposed on an end of valveblock 317, proximate an end 266 of the reservoir poppet 318, to preventsideways sliding of the reservoir poppet 318 during actuation of thepump. The pump bulb 316 is to be located over valve block 317, actuatingbar 310, reservoir poppet 318, and poppet support 320. As discussed inthe embodiments above, pump bulb 316 comprises major panels 312 and 314with textured surfaces that allow patients to easily identify thatportion of valve assembly 300. When a patient applies pressure to majorpanels 312 and 314, major panel 312 engages actuating bar 310. Reservoirpoppet 318, actuating bar 310 and poppet support 320 are described indetail below.

[0055] As illustrated in FIG. 8A, reservoir poppet 318 comprises anelongate rigid member 260 and a synthetic member 262. Synthetic member262 is disposed over a segment/post portion 264 of rigid member 260.Rigid member 260 is preferably made of a metal material, such as steel,stainless steel, or the like. Synthetic member 262 is preferably made ofa strong, durable plastic material, for example acetal, nylon and/orpolyester, to prevent undesired frictional contact with actuating bar310. Synthetic member 262 is rigidly attached to rigid member 260 bymolding, bonding, or the like. Synthetic member 262 prevents prematurewearing of reservoir poppet 318 and actuating bar 310. For example,synthetic member 262 prevents direct metal-on-metal contact betweenmetal reservoir poppet 318 and actuating bar 310. The addition of thesynthetic member 262 reduces the frictional interaction of reservoirpoppet 318 and actuation bar 310 that typically occurs at the end 266 ofreservoir poppet 318. Thus, the risk of marking or deforming reservoirpoppet 318 and actuation bar 310 is reduced, and the useful life of thetwo components is extended.

[0056] As shown in FIG. 8B, a poppet taper 777 provides a very usefulnovel feature. When poppet 318 is pushed back into the release ordeflation mode, taper 777 permits the lip seal 200 to separate frompoppet 318. This allows fluid from the cylinder to pass unimpededthrough the pump. Without taper 777, lip seal 200 would rest on poppet318 as shown in FIG. 8C. The arrangement of FIG. 8C requires pressure toopen lip seal 200 before fluid is allowed to pass from the cylinder tothe reservoir. Moreover, when the pressure drops below a minimum value,lip seal 200 closes on reservoir poppet 318 and traps pressurized fluidin the cylinder. This typically happens at a less than flaccid cylindercondition. Unfortunately, to force this pressurized fluid out of thecylinder when it is at this state, the patient must squeeze his penisand the cylinder to increase cylinder pressure and open the lip sealdesign.

[0057] As illustrated in FIGS. 7, 9 and 10A-C, actuating bar 310 is athin elongated member formed to comprise an actuating face 322 and anactuating arm 324 that are connected by an angle portion 326. A U-shapedportion 332 connects a connecting end 338 to actuating face 322. Asshown in FIG. 10A, actuating bar 310 is disposed within valve block 317by securement of end 338 into a valve block interface 336.

[0058] Connecting end 338 includes two forked portions 666, one of whichis shown in FIG. 9. As shown in FIG. 10A, actuating bar 310 is disposedwithin valve block 317 by securement of end 338 into a valve blockinterface 336. The forked portions 666 of connecting end 338 help holdactuating bar 310 in place.

[0059] Angle portion 326 provides actuating bar 310 with a spring forcethat is applied to an end of reservoir poppet 318 in the same manner asdescribed in the embodiments of above. Angle portion 326 permitsactuating face 322 of actuating bar 310 to extend along a side of thelength of valve block 317, while actuating arm 324 extends along a sideof the width of valve block 317. The configuration of actuating bar 310enables it to engage an end 266, e.g., the tip, of reservoir poppet 318.Actuating arm 324 includes, opposite angle portion 326, a curved portion325 for complementary engagement with reservoir poppet end 266. See FIG.10C. Preferably, curved portion 325 presents a smooth face to the sideof the pump shell when the pump shell acts on the curved portion 325 ofthe actuating bar 310.

[0060] As discussed in the embodiments above, when the patient graspsvalve assembly 300 in virtually any orientation and applies pressure,actuating bar 310 acts either directly or indirectly to open theappropriate check valves (FIG. 10C). Thus, when the patient grasps aportion of the pump and valve assembly 300 other than pump bulb 316,compression will result in the flexing of actuating bar 310. Duringcompression, actuating face 322 flexes inwardly and actuating arm 324flexes toward reservoir poppet end 266, as indicated by arrow A in FIG.10A. Actuating arm 324 moves into engagement with reservoir poppet end266. The movement of actuating arm 324 forces axial movement ofreservoir poppet 318 in the same direction as arrow A and into an openposition. The axial movement of reservoir poppet 318 permits fluid toflow through the fluid pathways to the reservoir and allows thecylinders to deflate.

[0061] When the patient ceases compression of the valve assembly 300,actuating face 322 returns to its original position. Actuating arm 324moves in a direction indicated by arrow B in FIG. 10A, and out offorceful engagement with end 266 (see FIG. 10B). This movement permitsreservoir poppet 318 to return to the position shown in FIG. 10A.

[0062] As disclosed in the embodiments above, angle portion 326 inactuating bar 310, and its resistance to flexing outwardly, creates adesirable stiffness, bias or spring force. Actuating bar 310 is capableof forcing reservoir poppet 318 into a position (see FIG. 10C) thatpermits the flow of fluid through the fluid pathways and back into thereservoir. For example, during patient compression of pump and valveassembly 300, curved portion 325 of actuating arm 324 enters engagementwith end 266. Actuating arm 324 applies the spring force to poppet end266 to force reservoir poppet 318 into the interior of valve block 317and into an open/active position. When actuating arm 324 is engaged withpoppet end 266, there is an opposing force created by the resistance ofreservoir poppet 318 to move into the open position. This opposing forcemay overcome the spring force and cause actuating arm 324 to improperlydeflect. Stated alternatively, this improper deflection occurs when theopposing force exerted against actuating bar 310 overcomes the inherentspring force and causes actuating arm 324 to bend backwards or buckle.

[0063] To prevent improper deflection, stiffening ribs 328 are formed onactuating bar 310, as shown by FIG. 9. Each rib 328 is a recess orimpression formed in actuating bar 310 and extends across angle portion326. Ribs 328 increase the strength and stiffness of angle portion 326,which increases the resistance to deflection during actuation. Thesurface area of angle portion 326 is disposed along a given plane. Ribs328 divide the surface area of angle 326 with recesses that extend intoanother plane. The portions of material extending in a different planeincrease the stiffness of angle 326. This increase in stiffnessdecreases the likelihood of improper deflection of actuating arm 324.The absence of improper deflection thus ensures full axial travel ofreservoir poppet 318 and attainment of the open position. Additionally,increasing the strength of angle 326 prevents any permanent deformationthat might occur due to repeated actuation. This resistance todeflection or bending helps prevent fatigue of actuating bar 310 andextends the useful life of the component. Although ribs 328 may beformed by a curved recess that extends in a plane perpendicular to thesurface of angle 326 as shown in the Figures, ribs 328 may exist in manydifferent orientations. A sufficient number of ribs 328 may be providedto angle 326 so as to achieve a predetermined deflection resistance. Forexample, two ribs 328 are provided in angle 326, as shown in FIG. 9.

[0064] As discussed above, when a patient compresses valve assembly 300to deflate the prosthesis, actuating face 322 flexes or pivots inwardlyabout U-shaped portion 332. This causes actuating face 324 to move intoengagement with poppet end 266 (FIG. 10B). The repeated application offorce to a particular area of actuation face 322, may cause permanentdeformation. As shown in FIG. 9, a recess formed in and disposed alongactuating face 322 defines a rib 330. Rib 330 strengthens and stiffensactuating face 322 to limit deformation. Rib 330 extends into a planeother than the plane created by the surface of actuating face 322 toincrease its resistance to bending. During patient compression, rib 330distributes the force applied throughout actuating face 322 rather thanpermit the compression force to be concentrated in one area. Thus,actuating face 322 properly flexes while resisting permanentdeformation. Rib 330 may be shaped to distribute the compression forcein any desired pattern. For example, as shown in FIG. 9, rib 330 may bea spoon-shaped impression centrally formed on actuating face 322 with alarger oval portion disposed toward U-portion 332 of actuating bar 310.An elongate portion 334 of spoon-shaped rib 330 extends toward angle326. This shape is preferred since the compression forces applied toflex actuating face 322 are evenly distributed over its entire surface.

[0065] The relatively thin composition of actuating bar 310 isbeneficial for several reasons. During actuation, U-portion 332 bends toflex actuating face 322 inwardly and actuating face 322 moves actuatingarm 324 into engagement with reservoir poppet 318. After actuation,U-portion 332, actuating face 322 and actuating arm 324 return to theiroriginal position. With an actuating bar formed with a thick material,U-portion 332 does not properly bend during actuation. In operation witha thick actuating bar 310, U-portion 332 does not bend, and connectingend 338 is pushed into valve block 317 causing its inner cavities todistort, such that annular ring 500 (FIG. 10A) of valve block 317becomes out-of-round and impedes or stops the movement of poppet 318 indirection A. Preferably, actuating bar 310 is a thin member made of amaterial with sufficient thickness and stiffness to provide thenecessary spring force to avoid improper deflection. For example,actuation bar 310 may be formed from a stainless steel sheet having athickness of approximately 0.0100 inches. Actuation bar 310 may be madeof various metal materials, plastic, or the like.

[0066] Since the engagement of actuating arm 324 to poppet end 266 isapplied from essentially one side of reservoir poppet 318, the appliedspring force is not completely along a longitudinal axis of reservoirpoppet 318. The spring force is applied to poppet end 266 in both theaxial and transverse/sideways directions. The sideways force has theunintended consequence of tipping reservoir poppet 318 sideways intovalve block 317. In response, valve block 317 deforms to cause reservoirpoppet 318 to be misaligned. This misalignment results in reservoirpoppet 318 being restrained from moving axially into valve block 317 toreach an activated/open position. As shown in FIGS. 10-11, a stiffpoppet support 320 is provided to prevent the misalignment of reservoirpoppet 318.

[0067] As shown in FIG. 11, poppet support 320 is an elongate, generallyL-shaped member comprising a shelf 342 at one end. Apertures 344 areprovided in a portion of support 320 to attach poppet support 320 tovalve block 317. See FIG. 10A. Poppet support 320 wraps around a portionof valve block 317 and rests against a portion of poppet end 266. Shelf342 provides a smooth surface for a segment of reservoir poppet 318 toslide axially along during reservoir poppet 318 travel between open andclosed positions. During actuation, curved portion 325 of actuating bar310 applies a spring force to move reservoir poppet 318 to an openposition. Poppet support 342 prevents sideways movement of reservoirpoppet 318 as the poppet is forced into the interior of valve body 317.Poppet support 320 ensures the proper alignment of reservoir poppet 318to easily move axially into valve body 317 to the open position.

[0068] Those skilled in the art will further appreciate that the presentinvention may be embodied in other specific forms without departing fromthe spirit or central attributes thereof. In that the foregoingdescription of the present invention discloses only exemplaryembodiments thereof, it is to be understood that other variations arecontemplated as being within the scope of the present invention.Accordingly, the present invention is not limited in the particularembodiments which have been described in detail therein. Rather,reference should be made to the appended claims as indicative of thescope and content of the present invention.

1. A pump assembly for an implantable prosthesis, comprising: a housinghaving an outer wall with at least a portion of the outer wall beingcompressible; a first flow valve positioned within the housing andhaving a seated and an unseated position; and a bar positioned withinthe housing and moveable between a first and a second position so thatwhen the bar is moved from the first position to the second position thebar causes the first flow valve to move from the seated to the unseatedposition.
 2. The pump assembly of claim 1, wherein the outer wallfurther comprises: a first compressible side wall positioned tointersect an axis defined by a path of travel of the first flow valvefrom the seated to the unseated position; a second compressible sidewall adjacent to the first compressible side wall, located such that afirst portion of the bar is adjacent to the first compressible side walland a second portion of the bar is adjacent to the second compressibleside wall so that if either the first or the second compressible sidewall is compressed, the bar is caused to engage the first flow valve andmove the first flow valve from the seated to the unseated position. 3.The pump assembly of claim 2 wherein the housing has a substantiallyrectangular configuration with the first compressible side wall beingshorter than the second compressible side wall.
 4. The pump assembly ofclaim 3 wherein the second portion of the bar is substantially parallelwith the second compressible side wall when the second compressible sidewall is in an uncompressed state.
 5. The pump assembly of claim 4wherein an interior angle formed between the first portion of the barand the second portion of the bar is obtuse.
 6. The pump assembly ofclaim 2 wherein the bar includes stainless steel.
 7. The pump assemblyof claim 2 wherein the bar includes plastic.
 8. The pump assembly ofclaim 3 wherein the first portion of the bar includes a curved free endwherein a curvature of the free end operatively associates with acurvature of the first flow valve.
 9. The pump assembly of claim 8wherein the curvature of the free end also operatively associates with acurvature of an interior portion of the outer wall.
 10. The pumpassembly of claim 2, further comprising: a pump bulb coupled to thehousing, wherein the pump bulb has a first exterior texture and thehousing has a second exterior texture that is different than the firstexterior texture.
 11. The pump of claim 10 wherein the second exteriortexture includes a plurality of raised panels.
 12. The pump of claim 11wherein the raised panels are circular.
 13. The pump assembly of claim 2further comprising a second flow valve positioned such that when thefirst flow valve is moved from the seated to the unseated position, thefirst flow valve contacts the second flow valve and moves the secondflow valve from a seated to an unseated position.
 14. An implantableprosthesis, comprising: a housing having a generally rectangularconfiguration defined by a first and a second minor side wall and afirst and a second major side wall wherein the major side walls arelonger than the minor side walls, wherein at least one of the major sidewalls and at least one of the minor side walls is compressible; a firstflow valve located within the housing and oriented to be generallyparallel with the major side wall and perpendicular to the minor sidewalls; and a bar located within the housing having a first portion thatis substantially parallel to the compressible major side wall and asecond portion that is angled toward the compressible minor side wall inproximity to the first flow valve so that a compression of either thecompressible major side wall or the compressible minor side wall causesthe bar to move so that the second portion contacts the first flow valveand moves it from a seated position to an unseated position.
 15. Theimplantable prosthesis of claim 14, further comprising: a valve blocklocated within the housing that supports and retains the first flowvalve and retains the first portion of the bar; a recess within thevalve block to receive the first portion of the bar as it is moved by acompression of either the compressible major or minor side wall; and atab formed by a portion of the valve block wherein the tab isdeflectable into the recess.
 16. The implantable prosthesis of claim 14,further comprising: a pump bulb coupled to the housing, wherein the pumpbulb has a first exterior texture and the housing has a second exteriortexture that is different than the first exterior texture.
 17. Theimplantable prosthesis of claim 16 wherein the second exterior textureincludes a plurality of raised panels.
 18. The implantable prosthesis ofclaim 17 wherein the raised panels are circular.
 19. The implantableprosthesis of claim 14 wherein the bar includes stainless steel. 20.(Canceled).
 21. (Canceled).
 22. (Canceled).
 23. (Canceled). 24.(Canceled).
 25. (Canceled).
 26. (Canceled).
 27. (Canceled).
 28. Aninflatable implantable prosthesis comprising: a pump assembly; said pumpassembly including a pump bulb; said pump assembly including at leastone internal check valve in a pathway extending from said pump bulb toan inflatable portion of said prosthetic; said pump assembly includingan actuator arm mechanically linking any randomly selected externalsurface of said pump assembly to one end of said at least one internalcheck valve.
 29. A prosthesis as set forth in claim 28, wherein saidactuator arm includes a first portion that extends along a length ofsaid pump assembly and a second portion that extends at an angle to saidfirst portion toward said at least one internal check valve.
 30. Aprosthesis as set forth in claim 28, wherein a portion of said pumpassembly has an external textured surface different than an externalsurface of the pump bulb.
 31. A prosthesis as set forth in claim 28,wherein said pump bulb is of a different size and shape from the rest ofthe pump assembly.
 32. A method of making a pump and valve assembly foran inflatable prosthesis, comprising: providing a valve block having atleast one actuable valve; providing a shell including a pump bulbcomponent; and attaching the shell to the valve block to complete thepump and valve assembly.
 33. A method of manufacturing a pump and valveassembly for an inflatable prosthesis, comprising: molding a unitaryvalve block; inserting at least one valve; molding a unitary shellincluding a pump bulb component; and joining the shell to the valveblock to complete the pump and valve assembly without requiring anyother components to be joined thereto.
 34. A pump and valve assembly foran inflatable prosthesis, comprising: a unitary molded valve block; anda unitary molded shell attached to the valve block wherein the shellinclude a pump bulb.
 35. A pump assembly for an implantable prosthesis,comprising: a housing having an outer wall with at least a portion ofthe outer wall being compressible; a first flow valve positioned withinthe housing and having a seated and an unseated position; and a barpositioned within the housing, the bar comprising a spring and beingmoveable between a first and a second position so that when the bar ismoved from the first position to the second position the bar causes thefirst flow valve to move from the seated to the unseated position. 36.The assembly of claim 35 wherein the bar has a bend connecting a firstportion and a second portion of the bar, at least one rib extending thefirst and second portions of the bar such that the bend augments thespring, the outer wall further comprising: a first compressible sidewall positioned to intersect an axis defined by a path of travel of thefirst flow valve from the seated to the unseated position; and a secondcompressible side wall adjacent to the first compressible side wall,located such that the first portion of the bar is adjacent to the firstcompressible side wall and the second portion of the bar is adjacent tothe second compressible side wall so that if either the first or thesecond compressible side wall is compressed, the bar causes the firstflow valve to move from the seated to the unseated position.
 37. Theassembly of claim 36 wherein the bar is a thin elongate member, an endportion of the second portion of the bar engaging an end of the firstflow valve when the bar is in the first position.
 38. The assembly ofclaim 36 wherein the second portion of the bar is substantially parallelwith the second compressible side wall when the second compressible sidewall is in an uncompressed state.
 39. The assembly of claim 38 whereinthe at least one rib extending across the bend is shaped to as to makethe bar stiff, such that resistance to deflection forces is enhanced.40. The assembly of claim 39 wherein the first portion of the barcomprises at least one rib centrally located on thereon, such that thewhen the first portion of the bar is compressed by the firstcompressible side wall compression forces exerted on the first portionof the bar are distributed substantially evenly along the first portionof the bar.
 41. The assembly of claim 35 wherein the first flow valvecomprises a synthetic portion and a metal portion.
 42. The assembly ofclaim 37 wherein a segment of the first flow valve includes a plasticmember disposed thereon such that the bar contacts the plastic memberwhen the bar is in the first position.
 43. The assembly of claim 36further comprising a support member coupled to the housing, wherein thesupport member contacts a portion of the first flow valve in such asmanner as to prevent sideways movement of the first flow valve.
 44. Theassembly of claim 43 wherein the support member further comprises ashelf in contact with the first flow valve.
 45. The pump assembly ofclaim 36 further comprising a second flow valve positioned such thatwhen the first flow valve is moved from the seated to the unseatedposition, the first flow valve contacts the second flow valve and movesthe second flow valve from a seated to an unseated position.
 46. Animplantable prosthesis, comprising: a housing having a generallyrectangular configuration defined by a first and a second minor sidewall and a first and a second major side wall wherein the major sidewalls are longer than the minor side walls, and wherein at least one ofthe major side walls and at least one of the minor side walls iscompressible; a first flow valve located within the housing and orientedto be generally parallel with the major side wall and perpendicular tothe minor side walls; and a bar located within the housing having afirst portion that is substantially parallel to the compressible majorside wall and a second portion that is angled toward the compressibleminor side wall in proximity to the first flow valve so that acompression of either the compressible major side wall or thecompressible minor side wall causes an actuating arm to cause the bar tomove so that the second portion contacts the first flow valve and movesthe flow valve from a seated position to an unseated position.
 47. Theimplantable prosthesis of claim 46 further comprising: a valve blocklocated within the housing that supports and retains the first flowvalve; a recess within the valve block to receive and retain the firstportion of the bar as it is moved by a compression of either thecompressible major or minor side wall; and a support member coupled tothe housing such that a portion contacts a portion of the first flowvalve.
 48. The implantable prosthesis of claim 46, further comprising: apump bulb coupled to the housing, wherein the pump bulb has a firstexterior texture and the housing has a second exterior texture that isdifferent than the first exterior texture; and the bar furthercomprising at least one rib extending across said bend.
 49. Theimplantable prosthesis of claim 47 wherein the support member has ashelf, the shelf contacting a portion of the first flow valve in such amanner as to resist sideways movement of the first flow valve when theflow valve is moving between the seated and unseated positions. 50.(Canceled).
 51. (Canceled).
 52. (Canceled).
 53. (Canceled). 54.(Canceled).
 55. A bar for incorporation into an inflatable implantableprosthesis which has a pump assembly including a pump bulb and at leastone internal check valve in a pathway extending from said pump bulb toan inflatable portion of said prosthesis, said bar comprising: a thinelongate member having a first portion connected to a second portion bya bend, the bend forming a spring such that a spring force may beexerted to mechanically link randomly selected external surfaces of saidpump assembly to one end of said at least one internal check valve; atleast one first rib extending across the bend to resist deformation ofthe bend and prevent diminishment of the spring stiffness; and at leastone second rib located on the first portion of the bar such that whenthe first portion of the bar is compressed, compression forces exertedon the first portion of the bar are distributed along the first portionof the bar.
 56. The bar of claim 55, wherein the first and second ribsare discontinuities in the bar shaped to resist deformation.
 57. The barof claim 56, wherein the at least one second rib is a spoon-shapedelement located in a central area of the first portion of the bar.
 58. Asupport member for an inflatable implantable prosthesis that includes apump assembly, and at least one internal check valve in a pathwayextending from a pump bulb to an inflatable portion of the prosthesis,said support member coupleable to the pump assembly, the support membercomprising a shelf for mechanical interaction with the internal checkvalve to resist transverse motion of the internal check valve.
 59. Amethod of making a pump and valve assembly for an inflatable prosthesis,comprising: providing a valve block having at least one actuable valve,the valve made of a metal material with a segment of the valve coveredby a plastic material; providing a shell including a pump bulbcomponent; providing a bar having two portions connected by a bendhaving at least one rib; providing a support member having a shelf, theshelf preventing transverse movement of the valve; and attaching theshell to the valve block to complete the pump and valve assembly.
 60. Aninternal check valve for an inflatable implantable prosthesis, whereinthe inflatable prosthesis comprises a pump assembly including a pumpbulb and a pathway extending from said pump bulb to an inflatableportion of said prosthesis, a bar having at least one rib extendingacross a bend, and a support member with a shelf, said internal checkvalve being sized and shaped to be insertable within said pump assembly,and being made of a metal material with a segment of the internal checkvalve having a plastic material disposed thereon, such that whenassembled, the plastic material of the check valve is adapted to engagea portion of the bar and the shelf of the support member.